Master quality agreements—aka technical quality agreements, common technical agreements, etc.—ensure that both parties in an outsourcing situation uphold product integrity—but only if the agreement is constructed well and is adhered to. Alex McClung, senior director of QA at contract manufacturer Pharmaceutics International, Inc. (Hunt Valley, Md.) shares rules of thumb for MQA’s that will lead to successful partnerships.
PhM: How would you define a Master Quality Agreement, and how much can the definition vary depending upon partners and their needs?
A.M.: The quality agreement documents the roles and responsibilities, expectations, timelines, deliverables, and quality standards between the “contract provider” and the “contract acceptor”. In other words, the MQA is a statement of who does what and how it gets done. The definition won’t vary much, but the content will vary considerably depending on the scope of the project and the boundaries of the contract relationship.
PhM: What are the critical aspects of the MQA between a drug developer and a CMO that performs commercial manufacturing? What absolutely must get agreed upon and conveyed?
A.M.: The most critical aspects are batch release responsibilities, who supplies API and excipients, how quality issues will be communicated and resolved, and control of third party outsourced processes (i.e. the contractor’s contractors).
PhM: What kinds of things should be left out of a quality agreement that may be in a supply agreement?
A.M.: The legalese of a formally binding contract is outside the scope of a quality agreement. This includes terms of payment, arbitration, force majeure, terminations, settlements, etc.
PhM: Who gets involved? How many people at both parties should have a hand in developing the agreement?
A.M.: I generally have QA, manufacturing, and analytical sign off on our side. These are the stakeholders. We take the position that the quality outcomes are a function of everyone’s participation.
PhM: Many times these agreements are viewed as terms that the contractor must live up to, but how do you ensure that the originating manufacturer bears an equal responsibility to perform and meet the specifics of the agreement?
A.M.: Each party has a role and responsibility; the agreement is never one-sided. We often use a quality agreement to communicate our expectations to the client. We have very specific language about how the client will qualify and document their API supplier, consequences of delayed communication, cost and ownership of investigations, etc.
PhM: How do the agreements account for potential changes in terms—for instance, a manufacturing process change or a regulatory issue that may crop up?
A.M.: We generally manage that through change control processes. Our quality agreement template has specific sections on change control, regulatory notifications, etc. We also define the lifecycle of the agreement: we drive for a complete review for current scope and validity every two years.
PhM: You had an experience in which you sat down side by side with the client in the same room and hammered out the agreement. What did you learn from this?
A.M.: Dialogue and negotiation are everything. Business runs on relationships. Drafting a document that defines your relationship over email is like internet dating; it works better live.
PhM: Can you share any other best practices? In your years of experience, what kinds of things have been essential to creating successful MQA’s?
A.M.: First, no matter how well you run a project, something will eventually go wrong. If you acknowledge this up front, and if you plan for resolution before occurrence, it helps a great deal. Second, even the best quality agreement cannot make up for a bad business fit. If the project does not match a contractor’s capability, all parties suffer.
